Easy@Home Blood Pressure Monitor

GUDID 00850253007185

EASY HEALTHCARE CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00850253007185
NIH Device Record Keyd10da2cf-9683-450a-9b7c-9b894a82f9ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Blood Pressure Monitor
Version Model NumberEBP-095
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007185 [Primary]
GS110850253007182 [Package]
Package: [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-08-01

On-Brand Devices [Easy@Home Blood Pressure Monitor ]

00850253007185EBP-095
00850003180090EBP-095
00810038630175EBP-095
10810038630028EBP-020

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